MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TEMA ELBOW; ULNAR STEM U5

Model Number	1575.14.010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We will send a final mdr once the investigation will be completed.
Event or Problem Description
Elbow revision surgery performed on (b)(6) 2021.During this revision ulnar liner small, ulnar body small and ulnar stem #5 previously implanted on (b)(6) 2020 have been replaced by implanting a new ulnar liner (same size), a new ulnar body (same size) and a ulnar stem #7.Cause for revision is unknown.Event happened in us.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of ulnar stem #u5 lot 1715495, no pre-existing anomaly has been found on a total of n.12 stems manufactured with the same lot and sterilization number.Neither explanted components nor x-rays were available to be retrieved and analyzed.Therefore, based on the few information available, we are not able to perform any further investigation.Hence, considering that: - checking the manufacturing charts of ulnar stem #u5 lot 1715495, no pre-existing anomaly has been found on a total of n.12 stems manufactured with the same lot and sterilization number.We can conclude that the event is not product related.Pms data: as we are not able to confirm the reason of the revision with certainty, we can not proceed with the calculation of an occurrence rate for this event.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final report.
Event or Problem Description
Elbow revision surgery performed on (b)(6) 2021, due to unknown reason.During this revision, the following components, implanted in the initial surgery on (b)(6) 2020, were removed: - ulnar body small right + screw (part code (b)(6), lot number 1814146, sterilization 1900275).- ulnar liner small right (part code (b)(6), lot number 18at1ru, sterilization 1900184).- ulnar stem #u5 (part code (b)(6), lot number 1715495, sterilization 1900181).The components above mentioned were replaced with the following ones: - ulnar body small right (part code (b)(6), lot number 2012988, sterilization 2000330).- ulnar liner small right (part code (b)(6), lot number 18at1ru, sterilization 1900225).- ulnar stem #u7 (part code (b)(6), lot number 1811263, sterilization 1900181).During the initial surgery, tema humeral components were implanted as well, but these components have not been explanted during the revision surgery.The patient's clinical history is the following: - initial surgery performed on (b)(6) 2020.- revision surgery performed on (b)(6) 2021, due to unknown reason (hereby reported) - the components were linked with tema axle small (part code (b)(6)) on (b)(6), 2021.This event was documented through the internal complaint (b)(4) and reported to the fda with mfr 3008021110-2022-00073.The patient is a female, date of birth (b)(6) 1983.Event happened in the united states.

• Brand Name: TEMA ELBOW
• Common Device Name: ULNAR STEM U5
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15319826
• Report Number: 3008021110-2022-00072
• Device Sequence Number: 5888260
• Product Code: JDC
• UDI-Device Identifier: 08033390128834
• UDI-Public: 08033390128834
• Combination Product (Y/N): N
• PMA/510(K) Number: K181362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1575.14.010
• Device Lot Number: 1715495
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown